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- New House bill targets LDT regulations
Rep. Neal Dunn, MD, (R-FL) has introduced the Enhancing Clinical Laboratory Innovation and Access (Enhancing CLIA) Act to update the regulation of laboratory-developed tests (LDTs).
What’s in the bill: The legislation would provide a framework where laboratories can opt for FDA or third-party reviews for certain LDTs.
- This change would affect laboratories by imposing new reporting requirements and regulatory standards.
- The act would amend both CLIA and the Federal Food, Drug, and Cosmetic Act to reflect current diagnostic practices and recognize third-party affirmations for companion diagnostics.
The big picture: The act underscores that LDTs would be regulated under CLIA, aligning with the ACLA v. FDA court decision in 2025.
- The bill proposes a transition period of two years for implementing the new framework, affecting how labs operate and report test results.
The CAP is reviewing the bill and engaging with its members to discuss how it could affect their practices.
- Any proposal addressing LDTs should strengthen patient protections without creating duplicative or overly burdensome requirements that could reduce access to testing, particularly in hospitals and community laboratories.